Efficacy and Safety, Tolerability of GA-AT0119 in IBS-C

NCT05240521 | Unknown

• 1 other identifier: CBSDEV21072020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

Brief Summary

Irritable bowel syndrome (IBS) is a common functional bowel disorder that imposes a considerable burden on health-related quality of life (QOL) worldwide. Irritable Bowel Syndrome (IBS) is a common digestive disorder affecting 7-21% of the general population. IBS with predominant constipation (IBS-C) is a subtype of IBS that accounts for more than a third of the IBS diagnosed. The study Sponsor, Devintec SAGL, presents GA-AT0119, which acts by forming a mechanical barrier on the intestinal mucosa thanks to xyloglucan and pea proteins avoiding the increased intestinal permeability, bacterial invasion to intestinal tissues, and subsequent intestinal inflammation. The formulation of GA-AT0119 is completed with chia seed powder which provides a laxative effect by retaining water in the intestine increasing stool bulk and accelerating fecal transit. There is increasing evidence that the pathophysiology of IBS is multifaceted involving mucosal inflammation, visceral hypersensitivity, microbial dysbiosis, dietary factors, and altered intestinal permeability (IP). Several studies have shown increased intestinal permeability in patients with irritable bowel syndrome. Serum zonulin, a biomarker of impaired increased permeability, is increased in patients' constipation-predominant irritable bowel syndrome compared to a healthy population and the levels are comparable to celiac disease.

Conditions

Irritable Bowel Syndrome With Constipation (IBS-C)

Outcome Measures

Primary Outcomes (12)

• Change from baseline in Subjective Symptom Improvement assessed through Likert scale (Discomfort, Bloating Abdominal Pain) at day 7, 15, 28, 56, 84,114,144

  The clinical symptoms that are going to be assessed through the 7 point Likert Scale are: Bloating, Discomfort, abdominal pain. Likert scale - level of acceptability: 1. \- Totally unacceptable 2. \- Unacceptable 3. \- Slightly unacceptable 4. \- Neutral 5. \- Slightly acceptable 6. \- Acceptable 7. \- Perfectly Acceptable

  144 days

• Change from baseline in BMI assessed at Day 7,15, 28, 56,84

  The BMI will be evaluated

  84 days

• Change from baseline in stool consistency will be assessed at Day 0, 7, 15, 28, 56, 84, 114, 144, through the Bristol Stool Scale.

  Type of stool will be assessed according to the Bristol Stool Chart ((Stool Type 1 - severe constipation, Stool Type 2 - mild constipation, Stool Type 3 - normal, Stool Type 4 - normal, Stool Type 5 - lacking fiber, Stool Type 6 - mild diarrhea, Stool Type 6 - severe diarrhea)

  144 days

• Change from baseline score in IBS-QoL questionnaire (Information Sheet on the Irritable Bowel Syndrome - Quality of Life Measure) at Day 7, 15, Day 28 and Day 56, Day 84, Day 114, Day 144

  Patients will respond to the IBS-QoL questionnaire. The individual responses to the 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life.

  144 days

• Change of Sickness Impact Profile score from Baseline to Day 28 and day 56, day 84, Day 114, Day 144

  The generic health status, the physical, mental and social aspects of health-related functioning and behavior aspectes will be measred through - The Sickness Impact Profile (All the items are scored dichotomously (no=0, yes=1); The items reported as "yes" are used to calculate the scores; higher scores indicate more health-related behavioral problems)

  144 days

• Change from Baseline (Day 0) to Day 7, 15, 28, 56 in Zonuline test

  Serum Zonuline test will be performed

  56 days

• Change from Baseline Day 0 to Day 7 in the VAS-IBS questionnaire (Visual Analogue Scale for Irritable Bowel Syndrome) evaluated by Patient Journal Daily on each symptom

  The VAS-IBS will be assessed through the Patient Journal. In the VAS-IBS the patients record the overall severity of each item on a 100 points line (very severe discomfort = 0 to no discomfort at all = 100).

  7 days

• Change from Baseline Day 0 to Day 7 in the VAS-IBS questionnaire (The Visual Analogue Scale for Irritable Bowel Syndrome) evaluated by Investigator at Day 15, Day 28 and Day 56, Day 84, Day 114, Day 144

  The Investigator will assess the symptoms in patients suffering from IBS - using the Visual Analogue Scale for Irritable Bowel Syndrome (VAS-IBS) questionnaire. In the VAS-IBS the patients record the overall severity of each item on a 100 points line (very severe discomfort = 0 to no discomfort at all = 100).

  144 days

• Number of AE occurrence

  Adverse events will be monitored during all the visits till the end of the study and reported accordingly

  144 days

• % of participants with withdrawal due to AE

  Withdrawal due to adverse events will be monitored during all the visits till the end of the study and reported accordingly.

  144 days

• Change from baseline in waist circumference assessed at Day 7,15, 28, 56,84

  The waist circumference will be evaluated

  84 days

• Change from baseline in number of stools will be assessed at Day 0, 7, 15, 28, 56, 84, 114, 144

  Number of stools will be assessed

  144 days

Study Arms (2)

ARM A: GA-AT0119 / Placebo

OTHER

Cross-over Study

Other: ARM A; Other: ARM B

ARM B: Placebo / GA-AT0119

OTHER

Cross-over Study

Other: ARM A; Other: ARM B

Interventions

ARM A OTHER

30 IBS-C patients will receive GA-AT0119 for 28 days, followed by a washout period of 28 days and Placebo for another 28 days

ARM A: GA-AT0119 / Placebo; ARM B: Placebo / GA-AT0119

ARM B OTHER

30 IBS-C patients will receive Placebo for 28 days, followed by a washout period of 28 days and GA-AT0119 for another 28 days

ARM A: GA-AT0119 / Placebo; ARM B: Placebo / GA-AT0119

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subjects over 18 years old;
• Subject willing to sign the informed consent;
• The ability to comply with study visits;
• Patients with constipation following diagnostic of IBS-C (Subtypes prevalent presentation of stool in IBS according to the Rome IV Criteria: IBS with constipation (IBS-C) - ( \>25% hard stools and \<25% loose stools)

You may not qualify if:

• Use of gelatin tannate, diosmectite, probiotics, racecadotril or any other drugs or medical devices known to alter gastrointestinal motility or secretion within four weeks prior to enrolment
• Chronic diarrhea caused by cystic fibrosis, coeliac disease, food allergy, diabetes Chronic diarrhea caused by lactose, fructose, or sorbitol intolerance
• Diagnostic of IBS-D
• Use of prebiotics, fiber supplements, laxatives, 5-HT4 agonists, antispasmodic, antidepressants with 4 weeks prior study Baseline visit
• Immunodeficiencies
• Abnormal thyroid function, a history of alcohol abuse or binge drinking, pancreatitis, sphincter of Oddi dysfunction, cholecystitis within the past 6 months, or known allergy to any of the components of the product or placebo
• The patient is a member of the investigational team or his/her immediate family
• Pregnant or breast-feeding women or women planning to become pregnant or breastfeed during the study
• Hypersensitivity to any of the ingredients of the study agents

Sponsors & Collaborators

• Devintec Sagl: lead
• CEBIS International: collaborator

Study Sites (4)

Outpatient clinic for individual practice for primary medical care Dr. Elenski EOOD

Plovdiv, Bulgaria

RECRUITING

Medical Center Prolet EOOD

Rousse, Bulgaria

RECRUITING

Medical Center Prolet EOOD

Rousse, Bulgaria

ACTIVE NOT RECRUITING

Ambulatory Practice for Primary Outpatient Medical Care SANA OOD

Sofia, Bulgaria

RECRUITING

Central Study Contacts

Maria Etropolska

CONTACT

00359 888 955 474; maria.etropolska@cebis-int.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: February 15, 2022
• Study Start: November 1, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: February 15, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

BU (4)